FDA.reportPublic FDA data

Medline

Primary DI
10197344026104
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDTEP93580AC
Catalog number
MDTEP93580AC
Device description
REPLACEMENT COVER,EQ PLUS 9000,35X80X7
Published
2024-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNMMattress, air flotation, alternating pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10197344026104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019734402610410197344026104

GMDN Terms#

Term, Definition table
TermDefinition
Waterproof bed mattress cover, reusableA device made of soft, waterproof material that is shaped to fit over a bed mattress to create a physical barrier to protect the mattress, prevent cross-contamination, and prevent exposure to soiling, typically bedwetting or spills of other liquids. It can be laundered for cleaning. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817012031881K-0 ECO-ZONEKAP MEDICALFNM2026-05-26
00817012031898K-0 ECO-ZONEKAP MEDICALFNM2026-05-26
04719893356922WellellWellell Inc.FNM2026-03-20
00860013391003ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00860013391010ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00860013391027ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00860013391034ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00860013391041ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00810178887040ViveVIVE HEALTH LLCFNM2026-03-06
00810178887057ViveVIVE HEALTH LLCFNM2026-03-06
H93392270Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-02-25
04719893356540WellellWellell Inc.FNM2026-02-11
00810178884193ViveVIVE HEALTH LLCFNM2026-02-02
00810178884483ViveVIVE HEALTH LLCFNM2026-01-30
05059441536024AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536031AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536048AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536055AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536062AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536079AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
08592654544112OPTICAREL I N E T spol. s r.o.FNM2026-01-07
00860014621895Thrive MedicalSupply Line MedicalFNM2025-12-26
00860015100412Thrive MedicalSupply Line MedicalFNM2025-12-26
00860015100429Thrive MedicalSupply Line MedicalFNM2025-12-26
04719873698608NACARILEX MEDICAL, INC.FNM2025-12-22
04719873698615NACARILEX MEDICAL, INC.FNM2025-12-22
14719873698629NACARILEX MEDICAL, INC.FNM2025-12-22
14719873698636NACARILEX MEDICAL, INC.FNM2025-12-22
05061105057455Protekt VX 5000PROACTIVE MEDICAL PRODUCTS, LLCFNM2025-12-18
10193489148305MEDLINEMEDLINE INDUSTRIES, INC.FNM2025-12-12